Expandable sheath with elastomeric cross sectional portions

ABSTRACT

An expandable introducer sheath for passage of implant delivery catheters, such as catheters for delivery of prosthetic heart valves. The expandable sheath balances the amounts, shapes and positions of various stiff and elastic structures in the sheath to selectively program the expandability and buckling stiffness of the sheath. The expandable sheath can include, for example, an expandable tubular layer that includes alternating stiff and elastic wall portions of a single radial thickness. The combination of stiff and elastic wall portions allow for torque and push strength to advance the expandable sheath while at the same time accommodating temporary expansion. The expandable sheath can also be reinforced with a tubular layer of braided fibers or a stent structure for additional strength. Other embodiments include selective use of slots or gaps at the distal end of a stiff wall portion to enhance expandability and distribute strain.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/880,111, filed Oct. 9, 2015 and entitled EXPANDABLE SHEATH WITHELASTOMERIC CROSS SECTIONAL PORTIONS, which claims the benefit of U.S.Provisional Patent Application Ser. No. 62/145,968, filed Apr. 10, 2015and entitled EXPANDABLE DELIVERY SHEATH. This application is also acontinuation of U.S. application Ser. No. 14/880,109, filed Oct. 9, 2015and entitled EXPANDABLE SHEATH, which claims the benefit of U.S.Provisional Patent Application Ser. No. 62/145,968 filed on Apr. 10,2015 and entitled EXPANDABLE DELIVERY SHEATH. All of the aforementionedapplications are hereby incorporated by reference herein in theirentireties and for all purposes.

BACKGROUND

Endovascular delivery catheter assemblies are used to implant prostheticdevices, such as a prosthetic valve, at locations inside the body thatare not readily accessible by surgery or where access without invasivesurgery is desirable. For example, aortic, mitral, tricuspid, and/orpulmonary prosthetic valves can be delivered to a treatment site usingminimally invasive surgical techniques.

An introducer sheath can be used to safely introduce a deliveryapparatus into a patient's vasculature (e.g., the femoral artery). Anintroducer sheath generally has an elongated sleeve that is insertedinto the vasculature and a housing that contains one or more sealingvalves that allow a delivery apparatus to be placed in fluidcommunication with the vasculature with minimal blood loss. Aconventional introducer sheath typically requires a tubular loader to beinserted through the seals in the housing to provide an unobstructedpath through the housing for a valve mounted on a balloon catheter. Aconventional loader extends from the proximal end of the introducersheath, and therefore decreases the available working length of thedelivery apparatus that can be inserted through the sheath and into thebody.

Conventional methods of accessing a vessel, such as a femoral artery,prior to introducing the delivery system include dilating the vesselusing multiple dilators or sheaths that progressively increase indiameter. This repeated insertion and vessel dilation can increase theamount of time the procedure takes, as well as the risk of damage to thevessel.

Radially expanding intravascular sheaths have been disclosed. Suchsheaths tend to have complex mechanisms, such as ratcheting mechanismsthat maintain the shaft or sheath in an expanded configuration once adevice with a larger diameter than the sheath's original diameter isintroduced.

However, delivery and/or removal of prosthetic devices and othermaterial to or from a patient still poses a risk to the patient.Furthermore, accessing the vessel remains a challenge due to therelatively large profile of the delivery system that can causelongitudinal and radial tearing of the vessel during insertion. Thedelivery system can additionally dislodge calcified plaque within thevessels, posing an additional risk of clots caused by the dislodgedplaque.

U.S. Pat. No. 8,790,387, which is entitled EXPANDABLE SHEATH FORINTRODUCING AN ENDOVASCULAR DELIVERY DEVICE INTO A BODY and isincorporated herein by reference, discloses a sheath with a split outerpolymeric tubular layer and an inner polymeric layer, for example inFIGS. 27A and 28 of '837. A portion of the inner polymeric layer extendsthrough a gap created by the cut and can be compressed between theportions of the outer polymeric tubular layer. Upon expansion of thesheath, portions of the outer polymeric tubular layer have separatedfrom one another, and the inner polymeric layer is expanded to asubstantially cylindrical tube. Advantageously, the sheath disclosed inthe '387 patent can temporarily expand for passage of implantabledevices and then return to its starting diameter.

Despite the disclosure of the '387 patent, there remains a need forfurther improvements in introducer sheaths for endovascular systems usedfor implanting valves and other prosthetic devices.

SUMMARY

Disclosed herein is an expandable introducer sheath for passage ofimplant delivery catheters, such as catheters for delivery of prostheticheart valves. The expandable sheath can minimize trauma to the vessel byallowing for temporary expansion of a portion of the expandable sheathto accommodate the delivery catheter, followed by a return to theoriginal diameter once the implant passes through. Generally, disclosedherein, are various embodiments balancing the amounts, shapes andpositions of various stiff and elastic structures in the sheath toselectively program the expandability and buckling stiffness of thesheath. The expandable sheath can include, for example, an expandabletubular layer that includes alternating stiff and elastic wall portionsof a single radial thickness. The combination of stiff and elastic wallportions allow for torque and push strength to advance the expandablesheath while at the same time accommodating temporary expansion. Theexpandable sheath can also be reinforced with a tubular layer of braidedfibers or a stent structure for additional strength. Other embodimentsinclude selective use of slots or gaps at the distal end of a stiff wallportion to enhance expandability and distribute strain.

A sheath of one embodiment includes at least one stiff wall portion andelastic wall portion arranged into an expandable tubular layer. Thestiff wall portion has a stiff wall radial thickness and extendsgenerally parallel to and partially around an elongate axis of thesheath and defines at least two edges. The two edges extend generallyaxially and between an inner surface and outer surface of the stiff wallportion. The stiff wall portion has an elastic wall radial thicknessequal to the stiff wall radial thickness and extends generally parallelto and partially around the elongate axis. The elastic wall portionextends between the edges of the stiff wall portion so as to define theexpandable tubular layer with a consistent radial thickness at any onecross-section. The expandable tubular layer has a starting profilesmaller than the implant and defines a lumen. The expandable layer isconfigured to temporarily expand at least at the elastic wall portion toallow passage of the implant through the lumen. The expandable layerthen returns to its original shape to approximate the starting profileafter passage of the implant through the lumen.

In another aspect, the at least one stiff wall portion includes aplurality of stiff wall portions. And, the at least one elastic wallportion includes a plurality of elastic wall portions. The stiff andelastic wall portions can alternate circumferentially around theelongate axis. Also, the sheath can include an elastic outer tubularlayer extending around the expandable tubular layer. The sheath can alsoinclude an intermediate tubular layer comprising a plurality of braidedfibers extending between the expandable tubular layer and the outertubular layer. The braided tubular fibers can also form an expandablemesh, wherein the elastic outer tubular layer is laminated onto theintermediate tubular layer. The sheath can also include a low frictiontubular layer coating the inner surface of the expandable tubular layer.The fibers can extend generally perpendicular to each other to form theexpandable mesh.

In another aspect, the two edges of each of the stiff wall portions canextend parallel to the elongate axis. And, the stiff wall portions canbe arc segments of the expandable tubular layer.

In another embodiment, the sheath includes a stiff wall portion and anelastic wall portion defining an expandable tubular layer. The stiffwall portion extends generally parallel to and partially around anelongate axis of the sheath and defines at least two edges. The twoedges extend generally axially and between an inner and outer surfacesof the stiff wall portion. The elastic wall portion extends generallyparallel to and partially around the elongate axis. The elastic wallportion extends between the edges of the stiff wall portion so as todefine the expandable tubular layer. The expandable tubular layer has astarting profile smaller than the implant and defines a lumen. And, theexpandable tubular layer is configured to temporarily expand at least atthe elastic wall portion to allow passage of the implant through thelumen and then return to approximate the starting profile after passageof the implant through the lumen. The elastic wall portion (or portions)can comprise 45 degrees to 90 degrees of an axial cross-section of theexpandable tubular layer.

The sheath can also include one or more elongate rods coupled to aninner surface of the elastic wall portion and extending generallyparallel to the elongate axis. The stiff wall portion and the elongaterods can have a lubricious inner surface configured to facilitatepassage of the implant. The elastic wall portion can also be part of anouter elastic tubular layer and the stiff wall portion can be embeddedin the outer elastic tubular layer. The lumen of the expandable tubularlayer can be larger where it is defined by the elastic wall portion thanwhere it is defined by the stiff wall portion.

In another aspect, a plurality of elongate rods are coupled to an innersurface of the elastic wall portion and the inner surface of the stiffwall portion. The elongate rods extend generally parallel to theelongate axis and inward into the lumen. The elongate rods can also bespaced circumferentially apart around the lumen of the expandabletubular layer.

In another embodiment, the sheath includes an elastic tubular layer andat least one stiff wall embedded in the elastic tubular layer. Aproximal portion of the stiff wall defines at least one firstlongitudinally extending gap and a distal portion defines at least onesecond longitudinally extending gap. A cumulative circumferential sizeof the at least one first longitudinally extending gap is smaller than acumulative circumferential size of the at least one secondlongitudinally extending gap. The sheath has a starting profile smallerthan the implant and defines a lumen. The sheath is configured totemporarily expand at the at least one first longitudinal gap and the atleast one second longitudinal gap to allow passage of the implantthrough the lumen and then to return to approximate the starting profileafter passage of the implant through the lumen.

The second longitudinally extending gap can extent from a distal end ofthe first longitudinally extending gap.

Also, the sheath can include twice as many second gaps as first gaps. Adistal end of each of the first longitudinally extending gaps can extendto a proximal end of a corresponding one of the second longitudinallyextending gaps. In another aspect, the sheath can include six secondlongitudinally extending gaps.

The at least one second longitudinally extending gap can include atleast a portion having a progressively, distally increasing cumulativecircumferential size.

In another aspect, the sheath includes a plurality of secondlongitudinal gaps extending linearly and defining a plurality of stiffwall fingers.

DESCRIPTION OF DRAWINGS

FIG. 1 is an exploded side view of a delivery catheter assembly;

FIG. 2 is a cross-sectional view of a sheath of one embodiment of thepresent invention;

FIG. 3 is a partial exploded view of the sheath of FIG. 2;

FIG. 4 is an enlarged view of a distal end of the sheath of FIG. 2;

FIG. 5 is an enlarged view of a proximal end of the sheath of FIG. 2;

FIG. 6A is an enlarged view of a sheath of another embodiment with acapsule passing therethrough;

FIG. 6B is a cross sectional view of the sheath of FIG. 6A;

FIG. 7 is a cross sectional view of a sheath of another embodiment;

FIG. 8A is a schematic of another implementation of a delivery sheathwith increasing elasticity approaching the distal end region;

FIGS. 8B-8D are cross sectional schematics of the delivery sheathimplementation shown in FIG. 8A;

FIG. 9A is a schematic of another implementation of a delivery sheathwith increasing elasticity approaching the distal end region;

FIGS. 9B-9D are cross sectional schematics of the delivery sheathimplementation shown in FIG. 9A;

FIG. 10A is a schematic of another implementation of a delivery sheathwith increasing elasticity approaching the distal end region;

FIGS. 10B-10D are cross sectional schematics of the delivery sheathimplementation shown in FIG. 10A;

FIG. 11A is a schematic of another implementation of a delivery sheathwith increasing elasticity approaching the distal end region;

FIGS. 11B-11D are cross sectional schematics of the delivery sheathimplementation shown in FIG. 11A;

FIG. 12A is a schematic of another implementation of a delivery sheathwith increasing elasticity approaching the distal end region.

FIGS. 12B-12D are cross sectional schematics of the delivery sheathimplementation shown in FIG. 12A;

FIG. 13 is a schematic of assembly of two sheaths into a combinationsheath of another embodiment of the present invention;

FIGS. 14-16 are cross-sections of embodiments sheaths having expandablethinned wall sections;

FIGS. 17-19 are cross-sections of embodiments of sheaths having wires orstrips reinforcing expandable walled tubes;

FIG. 20 is a partial perspective view of a stent for an end of a sheathof another embodiment of the present invention;

FIGS. 21-23 are perspective views of an embodiment of a stiff wallstructure of a sheath having a distal stent portion progressivelyopening to increase its lumen diameter;

FIG. 24 is a cross sectional view of an exemplary implementation of anouter tubular layer of a sheath;

FIG. 25 is a magnified view of part of the outer tubular layer of FIG.24, showing the cross section of longitudinal rods in greater detail;

FIG. 26 shows a cross section of an exemplary embodiment includinglongitudinal rods embedded in the outer tubular layer and protrudinginto an elastic lumen;

FIG. 27 shows a cross section of an exemplary embodiment includinglongitudinal rods embedded in the outer tubular layer and protrudinginto the elastic lumen and outward from the outer surface of the outertubular layer;

FIG. 28 shows a cross section of an exemplary embodiment includinglongitudinal rods embedded in the outer tubular layer, where some rodsprotrude into the elastic lumen and others protrude outward from theouter surface of the outer tubular layer;

FIG. 29 shows a cross section of an exemplary embodiment includinglongitudinal rods embedded in the outer tubular layer and the innertubular layer;

FIG. 30 shows a cross section of another exemplary embodiment includinglongitudinal rods embedded in the outer tubular layer and protrudinginto the elastic lumen;

FIG. 31 shows a side view of the sheath with an implant passingtherethrough;

FIG. 32 shows a flared implementation of a distal portion of the sheath,where the flared portion is folded into a compressed configuration;

FIG. 33 shows the distal portion of FIG. 32, where the flared portion isunfolded and expanded; and

FIG. 34 shows a cross section of the distal portion of FIG. 32, wherethe flared portion folded into a compressed condition.

DETAILED DESCRIPTION

The following description of certain examples of the inventive conceptsshould not be used to limit the scope of the claims. Other examples,features, aspects, embodiments, and advantages will become apparent tothose skilled in the art from the following description. As will berealized, the device and/or methods are capable of other different andobvious aspects, all without departing from the spirit of the inventiveconcepts. Accordingly, the drawings and descriptions should be regardedas illustrative in nature and not restrictive.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedescribed methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties, orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract, and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract, and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Ranges may be expressed herein as from “about” oneparticular value, and/or to “about” another particular value. When sucha range is expressed, another aspect includes from the one particularvalue and/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another aspect. It will befurther understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where said event or circumstance occurs and instances where itdoes not.

Throughout the description and claims of this specification, the word“comprise” and variations of the word, such as “comprising” and“comprises,” means “including but not limited to,” and is not intendedto exclude, for example, other additives, components, integers or steps.“Exemplary” means “an example of” and is not intended to convey anindication of a preferred or ideal aspect. “Such as” is not used in arestrictive sense, but for explanatory purposes.

Disclosed herein is an expandable introducer sheath for passage ofimplant delivery catheters, such as catheters for delivery of prostheticheart valves. The expandable sheath can minimize trauma to the vessel byallowing for temporary expansion of a portion of the expandable sheathto accommodate the delivery catheter, followed by a return to theoriginal diameter once the implant passes through. Generally, disclosedherein, are various embodiments balancing the amounts, shapes andpositions of various stiff and elastic structures in the sheath toselectively program the expandability and buckling stiffness of thesheath. The expandable sheath can include, for example, an expandabletubular layer that includes alternating stiff and elastic wall portionsof a single radial thickness. The combination of stiff and elastic wallportions allow for torque and push strength to advance the expandablesheath while at the same time accommodating temporary expansion. Theexpandable sheath can also be reinforced with a tubular layer of braidedfibers or a stent structure for additional strength. Other embodimentsinclude selective use of slots or gaps at the distal end of a stiff wallportion to enhance expandability and distribute strain.

Disclosed herein are elongate delivery sheaths that are particularlysuitable for delivery of implants in the form of implantable heartvalves, such as balloon-expandable implantable heart valves.Balloon-expandable implantable heart valves are well-known and will notbe described in detail here. An example of such an implantable heartvalve is described in U.S. Pat. No. 5,411,552, and also in U.S. PatentApplication Publication No. 2012/0123529, both of which are herebyincorporated by reference. The elongate delivery sheaths disclosedherein may also be used to deliver other types of implantable devices,such as self-expanding implantable heart valves, stents or filters. Theterms “implant” and “implantable” as used herein are broadly defined tomean anything—prosthetic or not—that is delivered to a site within abody. A diagnostic device, for example, may be an implantable.

The term “tube” or “tubular” as used herein is not meant to limit shapesto circular cross-sections. Instead, tube or tubular can refer to anyelongate structure with a closed-cross section and lumen extendingaxially therethrough. A tube can also have some selectively locatedslits or openings therein—although it still will provide enough of aclosed structure to contain other components within its lumen(s).

FIG. 1 illustrates a delivery catheter assembly 1 including an elongate,expandable delivery sheath 3 with a lumen to guide passage of an implantdelivery catheter supporting a prosthetic implant 5, such as aprosthetic heart valve. At a proximal end the sheath 3 includes ahemostasis valve that prevents leakage of pressurized blood and a hub 4for connecting with sheath 3. The delivery catheter assembly 1 caninclude a steerable guide catheter 7 (also referred to as a flexcatheter) and a balloon catheter 9 extending through the guide catheter7. The delivery catheter assembly 1 can also include a capsule 13 whichhas an enlarged diameter to hold the implant 5 mounted on the balloon ofthe balloon catheter 9.

Generally, during use, the sheath 3 is passed through the skin ofpatient (usually over a guidewire) such that the distal end region ofthe sheath 3 is inserted into a vessel, such as a femoral artery, andthen advanced to a procedure site—such as over the aortic arch to anative aortic heart valve. The nose of the balloon catheter and capsule13 is inserted through the hemostasis valve at the proximal end of thesheath 3. The steerable guide catheter 7 is used to advance the nose ofthe balloon catheter 11 and capsule 13 through to and out of the end ofthe sheath 3. The implant 5 is then advanced out of the capsule 13 andexpanded into the native heart valve, such as by balloon inflation or byself-expansion.

The implementations of the delivery sheath shown herein can provideaccess for other implants and delivery devices needing transientexpansion to facilitate passage of the implants or portions of thedelivery devices. For example, in some implementations, the deliverysheath can be used to deliver oversized balloon catheters forangioplasty procedures. The term “implant” as used herein need not be apermanent implant—for example the balloon is an implant temporarily—butcould be any device delivered into the body for a procedure.

FIGS. 2-5 show one embodiment of sheath 3 including a wall structurehaving a tip 28 on its distal end and a flared portion on its proximalend 30 and defining a lumen 32 extending therebetween. The wallstructure includes an outer elastic layer 20, an intermediate mesh layer22, a mixed expandable layer 24 and an inner lubricious low-frictionliner or layer 26. Generally, the flared proximal end 30 is sized andshaped to accept a distal male end of a hub structure containing, amongother things, a hemostasis valve to mediate leakage during insertion ofdelivery catheters through the lumen 32 of the delivery sheath 3. Thesheath 3 can be sized for delivery of prosthetic implants in the form,for example, of stent-mounted soft-tissue heart valves. For such anapplication, the sheath can have an outside diameter 0.260 inches and aninside diameter of 0.215 inches. Those diameters can vary with the sizeof the implant and/or the type of implant or other application.

As shown in FIG. 4, the distal tip 28, which has a tapering cylindricalconstruction, has a proximal taper 34, a distal taper 36, an innersurface 38 and a rounded leading edge 40. The proximal taper 34 has arelatively slight angle with respect to the parallel outer walls of theouter elastic layer 20. Generally, the tip has an outside diameter ofabout 0.25 inches at the distal end of the proximal taper and an outsidediameter of about 0.26 inches at the proximal end of the proximal taper34. The distal taper 36 has a higher angle increasing to about 20degrees. The distal taper 36 has a length of approximately 0.060 inches.The leading edge 40 has a rounded radius of about 0.01 inches. Theoutermost diameter of the leading edge is 0.206 inches and the innermost diameter of 0.187 inches.

The inner surface 38 supports a progressively thinning, distallytapering portion of the mixed expandable layer 24 and inner lubriciouslayer 26—with the layers getting thinner in the distal direction.Together the inner surface and distally tapering portion of the layers24, 26 define a distal portion of the lumen 32 through which the implant5 and capsule 13 can exit.

At its proximal end the distal tip 28 includes an inner annular surface42 and an outer annular surface 44. The inner annular surface isrecessed within the proximal end of the distal tip 28 and the outerannular surface is on the proximal-most edge of the distal tip 28. Theinner annular surface 42 is configured to receive and abut a distal edgeof the mesh layer 22 and the outer annular surface 44 is configured toabut the distal edge of the outer elastic layer 20.

When assembled to the distal end of the layers 20, 22, 24 and 26 thedistal tip 28—which is constructed of a relatively smooth, rigidmaterial—provides support for advancement of the distal end of thesheath 3. The tapers and rounded outer edges minimize trauma whenadvancing through body lumens. Also, the distal tip 28 helps to maintainthe end diameter of the sheath 3 after passage of the implant 5 andcapsule 13.

The outer layer 20 has a tubular shape and is preferably constructed ofa soft elastomeric material, such as a PEBAX or polyether block amidematerial, so as to easily expand in response to forces and return to itsoriginal dimensions. Also, the elastomeric properties urge the moreinner layers to contract back to their original shapes. The outer layercan have an outer diameter of 0.260 inches and is the largest diameterof the layers making up the sheath 3. The outer layer 20 extends aroundand laminated onto the mesh layer 22 extending through its lumen.

The mesh layer 22 is preferably formed of a textile that is comprised ofless-elastic components that obtain flexibility and some push stiffnessfrom woven or knit construction. For example, the mesh layer can beconstructed of a PET (polyethylene terephthalate) rope or threadmaterial that is woven into a flexible mesh or a sleeve or tube withporous openings to promote expansion and flexibility. The mesh layer 22can be formed as a plurality of braided fibers. FIG. 3, for example,shows the tubular shape of one embodiment of the mesh layer 22 whereinone group of threads extends perpendicular to another group of threads.Wires or metal could also be used to construct the mesh layer 22, suchas woven superelastic nitinol wires with high elastic strain limits.

FIG. 5 shows a cross section of the flared proximal end of sheath 3.Like the distal end, the proximal end includes an outer elastic layer20, a middle mesh layer 22, a mixed expandable layer 24 and an innerlubricious liner or layer 26. The most proximal region has a firstannular portion 17 that is wider than the remainder of sheath 3. Thelayers 20, 22, 24, and 26 narrow sharply moving distally from the firstannular portion of the proximal end 30, forming shoulder 21. Theshoulder 21 and first annular portion 17 are configured to connect tothe hub 4 of the delivery system 1. Moving distally from the shoulder21, the layers extend distally to form a second annular portion 19. Thewalls of the first and second annular portions 17, 19 extendsubstantially parallel to the longitudinal axis 2 of the sheath 3, andthe second annular portion 19 extends a greater distance than the firstannular portion 17. Moving distally from the second annular portion 19,the layers 20, 22, 24, and 26 narrow again to form a taper 23. Taper 23makes a smaller angle with the longitudinal axis 2 than shoulder 21.Taper 23 also extends a greater distance along the longitudinal axis 2than shoulder 21.

Referring again to FIG. 3, the mixed, expandable layer 24 is constructedof a mixture of alternating full-thickness portions, including softportions 46 and hard portions 48. The soft portions 46 are constructedof elastomer material—such as materials similar to the outer layer20—that provide elasticity to the expandable layer 24. The hard portions48 are constructed of a relatively stiff material and thus provide somecolumnar stability for advancing the sheath 3 against resistance of abody lumen. The number and spacing of the portions 46, 48 can beadjusted per application. Greater amounts or dimensions of stiffportions 48 can be included for more stiffness. Greater number ordimensions of soft/elastomeric portions 46 can be included for improvedexpandability and flexibility. TECOFLEX, an aliphatic polyetherpolyurethane, is one material that can be used for the stiff portions48.

The portions have a radial thickness from the inside to outside diameterthat is equal about the circumference of the layer 24. Also, each of theportions includes a pair of edges 25 between the hard and soft portionsthat extend between the inner and outer surfaces of the layer 24. Thepair of edges can also extend longitudinally, in parallel to the longaxis of the sheath 3. The soft/elastomeric portions 46 alternate withthe hard portions 48 in arc-segments, their edges in abuttingattachment, to form the tubular structure (with a consistent or constantwall thickness) of the mixed expandable layer 24. The hard and softarc-segments can be equally sized, or they can vary in size.

The inner lubricious layer 26 coats or is adhered on inside surfaces ofthe expandable layer 24. The layer 26 is preferably a low-friction layer(such as PTFE) and can include a tie-layer attaching the lubriciousmaterial to the expandable layer 24. Advantageously, the composite ofthree layers—including an elastic outer layer, mesh layer andalternating hard/elastomeric layer and inner lubricious liner canprovide a good balance of stiffness, expansion/recovery and lowresistance to passage of implants.

FIGS. 6A shows the delivery sheath 3 of another embodiment of thepresent invention with the capsule 13 carrying a stent-mounted heartvalve or other prosthetic implant 5 passing through the sheath's lumen32. (For example, the implant can be a 29 mm stent-mounted prostheticheart valve.) The capsule 13 is passing in a proximal to distaldirection. As used herein, “distal” (marked “D” in FIG. 6A), meanstowards the implantation site, and “proximal” (marked “P” in FIG. 6A)means away from the implantation site. The delivery sheath 3 cancomprise a transparent or semi-transparent material through which can beseen the capsule 13. Generally, the sheath of FIGS. 6A and 6B exhibitsthe ability to temporarily expand for passage of an implant 5 and thenreturn back to its normal diameter afterwards. Also, the sheath 3 caninclude multiple rods 50, that can be seen through the sheath, and thatfacilitate lower friction passage of the capsule 13.

FIG. 6B shows a cross section of the delivery sheath 3 including a stiffwall portion 52, an elastic wall portion 54 and the rods 50. The stiffwall portion 52 has a partial circular, or arc-shaped, or C-shapedcross-section with a consistent wall thickness within the cross-section.The C-shape of the stiff wall portion has a pair of edges 56 that extendbetween the inner and outer surfaces of the stiff wall portion 52.Perpendicular to the cross-section, the two edges extend generally alongthe length of the stiff wall portion 52 and in the direction of, andparallel to, the elongate axis of the delivery sheath 3.

The elastic wall portion 54 extends between the free edges 56 of thestiff wall portion 52 to define an expandable tubular layer and closethe lumen 32 of the sheath 3. As shown in FIG. 6B, the elastic wallportion generally has a shorter arc-length than the stiff wall portion52 and is positioned further away radially from the axis of the sheath 3than the inside surface of the stiff wall portion 52. This additionalradial clearance provides room for the three rods 50 to extend into thelumen 32. The elastic wall portion 54 can comprise an angle 58 of atleast 20 degrees, or as much as 45 to 90 degrees of the cross-section ofthe sheath 3. The combination and proportions of the elastic and stiffwall portions 54, 52 provide for the temporary expansion and return ofthe lumen diameter 32 during passage of the implant 5.

The elastic wall portion 54 can be part of an outer elastic tubularlayer 62 that externally encapsulates the stiff wall portion 52 in aseamless elastomeric layer. In this manner, the elastic tubular layer 62helps to seal off the lumen 32 and to urge the C-shaped stiff wallportion 52 back to its original diameter when no longer under pressurefrom a passing implant. Although the sheath of FIGS. 6A and 6B can havea range of dimensions to suit different applications, the stiff wallportion 52 can, for prosthetic valve delivery purposes, range from 0.002inches to 0.020 inches in thickness, including about 0.015 inches. Theouter portion of the elastic tubular layer 62 adds about another 0.002inches to 0.020 inches, and in particular about 0.005 inches. In oneapplication, then, the total thickness of the sheath 3 wall can be about0.020 inches. The unexpanded lumen 32 can have a diameter from 0.050 to0.250 inches, such as 0.156 inches.

FIG. 6B shows three of the rods 50 embedded into the elastic wallportion 54 and extending into the lumen 32 of the sheath 3. The rods 50are elongate structures with extruded cross sections—such as acylindrical shape with a circular cross-section—that extend along thelongitudinal axis of the sheath 3. The rods 50 of FIG. 6B are equallyspaced from each other in a circumferential direction between the edges56 of the C-shaped stiff wall portion 52. Advantageously, the spacing ofthe rods 50 can increase, as shown in FIG. 6A, during passage of thecapsule 13 with stretching of the elastic wall portion 54. Thus the rodscan provide some additional stiffness and reduce the surface area andfriction that would otherwise be present between the elastic wallportion and the passing implant or capsule without much impact on theexpandability of the sheath. As can be seen, at least about half of thecross-section of the rods 50 extends into the lumen 32.

The C-shaped stiff wall portion 52 can be comprised of a range of stiffmaterials, such as a high-density polyethylene or nylon which providesbuckle resistance, pushability, torqueability and a relatively stiffbody for the sheath 3. The combination of the elastomeric soft portion46 helps to mediate kinks of the sheath and to bias against the openingtendency of the stiff wall portion 52. A proximal end of the expandabletubular layer including the wall portions 52, 54 and the outer elastictubular layer 62 can be flared to provide for hub attachment. Also, atip could be constructed from the same elastomeric material as the wallportion 54. The tip could include radiopaque properties and be heatfused to the outer tubular layer 62. Manufacture is fairly easy sincethe components of the sheath 3 can be co-extruded in a single operation.

FIG. 7 shows another embodiment of sheath 3 including wall portions 52,54 and rods 50 similar to the sheath 3 in FIGS. 6A and 6B. In thisembodiment, however, the edges 56 of the stiff wall portion 52 areoriented to be within a common plane. The elastic wall portion 54 alsohas a thickness matched to the stiff wall portion 52, as opposed tohaving the encapsulating outer elastic tubular layer 62. The elasticwall portion 54 also takes up a larger angle 58 than the embodimentshown in FIGS. 6A and 6B.

The sheath 3 also includes a larger number of rods 50 which are equallyspaced circumferentially about the entire lumen 32. The rods 50 areconnected to the inside surfaces of both the stiff wall portion 52 andthe elastic wall portion 54. The rods 50 have a semi-circular extrudedcross-section. The additional rods 50 can further reduce contact areaand the associated friction. The rods 50 can be comprised of stiff,relatively lubricious material to further facilitate sliding. The rods50 on the stiff wall portion 52 can allow reduction of the overallstiffness of the wall portion as the rods help to increase stiffness.

FIGS. 8A-8D show embodiments wherein the sheath 3 includes an elastictubular layer 66 having covering one or more stiff wall portions 68. Theelastic tubular layer 66 can be a seamless outer layer that guardsagainst blood or fluid leakage. The stiff wall portions define one ormore gaps 70. Generally, the cumulative circumferential amount of thecross-section taken up by the gaps 70 is proportional to the resistanceto expansion of the sheath 3 at that particular longitudinal position.FIGS. 8A-8D, for example, show the cumulative amount of the gaps 70increasing distally so that the amount of compression exerted on theimplant drops in the distal direction. This can be advantageous as thefriction and/or other resistance to advancement of the capsule 13 withinthe sheath can increase with increase in distance of travel—the drop inexpansion resistance can offset somewhat the increased push resistance.

The cross-section shown in FIG. 8D, for example, is taken from a moreproximal position and the embedded stiff wall portion 68 takes upsignificantly more than half of the circumference of the sheath 3. Thesingle gap 70 between ends of the stiff wall portion 68 is about 45degrees of the circumference forming a C-shaped tube similar to thestiff wall portion 52 described above. Moving distally to thecross-section shown in FIG. 8C shows an additional set of four smallergaps 70 added to the larger gap. These gaps, as shown in FIG. 8A, tendto define the stiff wall portion 68 into discrete fingers 74. With theincrease of the gap size in proportion to the size of the stiff wallportion 68, the expansion stiffness of the sheath 3 drops. Thecross-section shown in FIG. 8B is at the distal end and now the stiffwall portion 68 is not present, substantially increasing theexpandability of the distal end of the sheath 3.

The gaps 70 can have a range of sizes and positioning, although the gapsshown in FIGS. 8A-8D extend longitudinally and generally parallel toeach other. The smaller gaps are circumferentially arranged and spacedfrom each other and from the larger gap. The multiple gaps 70 withregular spacing facilitate even expansion of elastic tubular layer 66.The full axial length gap can also be of similar circumferential size asthe other gaps 70 for a more even distribution of expansion. Forexample, for six gaps, a 300% strain of a C-shaped tube is divided into50% at each location. In contrast, tips with a single gap have morelocalized expansion of the layer 66 and some risk of fracture.

It should be noted that the term ‘axial’ as used herein is not limitedto a straight axis but instead is referring to the general instantaneousdirection of a longitudinal structure. In other words, the axis bendswith a bend of the elongate structure.

FIGS. 9A-9D show another embodiment wherein the sheath 3 has a singleone of the gaps 70 extending longitudinally and then a diagonal cutforming a distal-facing diagonal surface. The diagonal cut serves toprogressively decrease the amount of cross-section occupied by the stiffwall portion 68 as it extends in the distal direction, as shown by FIGS.9D, 9C and 9B.

FIGS. 10A-10D show another embodiment wherein the sheath includes a pairof gaps 70 on opposite sides of the stiff wall portion. The pair of gapsexpand in the distal direction, being smallest in diameter at theproximal cross-section of FIG. 10D, making a step increase in size tothe cross-section of FIG. 10C. At the final transition, the stiff wallportion 68 disappears for cross-section FIG. 10B. This pattern providesa step decrease in resistance to expansion with each transition in thedistal direction.

FIGS. 11A-11D show another embodiment wherein one of the gaps 70disappears when the stiff wall portion starts a pair of convergingdiagonal surfaces 72. The diagonal surfaces converge to a single pair ofopposing fingers 74. Again, the change in proportion of circumferenceoccupied by the stiff wall portion 68 and gaps 70 adjusts the resistanceto expansion of the distal end of the sheath 3.

FIGS. 12A-12D show a combination of some of the prior concepts, whereinthe sheath 3 includes the diagonal surface 72 converging to one finger74.

In the embodiments of FIGS. 8A-12D, the elastic tubular layer 66 andstiff wall portion can move independently of one another for freerexpansion. This can be supplemented with addition of a tip region 76,such as by reflowing a soft expandable tube or coating over the distalend of the cuts defining the gaps 70 in the C-shaped stiff wall portion68. Adding the tip can soften and contour the tip for easier insertionof the sheath 3 as well as protect and cover the distal end of the stiffwall portion 68. In FIGS. 8A-8D the tip region 76 covers some or all ofthe longitudinal length of the fingers 74 while the remainder of thestiff wall portion with only the single C-shaped cross-section (e.g.,FIG. 8D cross-section) is left independent of the elastic tubular layer66 for free expansion. In FIGS. 9A-12D, the tip region can start distalof the termination of the single gap defining the C-shaped cross sectionof FIG. 9D.

Although embodiments of the sheath 3 disclosed herein have particularlayer constructions, they can include additional layers extending aroundthe inside or outside of the layers depicted in the figures. Forexample, in some implementations, an undercut/bard or tie layer can beincluded to keep the stiff wall portion 68 attached to the elastictubular layer 66. In some implementations, a lubricious outermost layercan be included. The lubricious outermost layer can include a slipadditive to increase outer surface lubricity.

In some implementations, such as the one shown in FIG. 6B, the first andsecond layer 54, 62 and wall portion 52 (which is another layer) arebound together, for example, due to fabrication methods that includecoextrusion, heat bonding, glue, or another fixative material.Coextruded implementations are particularly advantageous as they aresimple and inexpensive to manufacture. Coextrusion also reducesdelamination of outer circumferential layers from inner circumferentiallayers. In other implementations, the layers are not fully bound and areat least partially, and possibly fully, rotatable with respect to eachother. For rotatable implementations, the circumferential tensionexperienced when an implant 5 is passing through is distributed aroundthe layers 20, 54 and 66, instead of being localized to particularlocations. This reduces the chance of rupturing those outer layers. Insome implementations, the layers are bound together over certain lengthsof the sheath 3, and rotatable over other lengths of the sheath 3. Insome implementations, the first and second circumferential layers arebound together only at the distal end region of the sheath 3.Selectively allowing rotation of some portions of the layers allows forsome improved tear resistance while preserving some element ofstructural stiffness. In some implementations, the proximal end ofsheath 3 can be flared to attach to external components of the sheath.

In some implementations, various portions of the illustrated embodimentscan be supplemented with the longitudinal rods 50. The rods can extend,either partially or fully, along the length of the inner-most surfacedefining the lumen 32 of the sheath. The longitudinally extending rodscan, for example, be supported by the inner-most surface. Here the term“supported by” can mean that the rod is in contact with or extendsthrough that inner surface. For example, the rod can be adhered to orformed on the inner most surface. In some implementations, thelongitudinally extending rods can be fully embedded within theinner-most layer. In other implementations, longitudinally extendingrods 50 can be partially embedded within the layer, and partiallyprotruding into the inner lumen of the sheath, such as is shown in FIG.6B.

The height and width of the longitudinally extending rods 50, and thusthe amount of the sheath cross-section devoted to the non-elastomericportions, can vary along the length of sheath 3. A width 43 of thelongitudinally extending rods 50 can be, for example, from 0.001 to 0.05inches. The rods 50 can be circular, ellipsoidal, polygonal,rectangular, square, or a combination of parts of the afore-listedshapes when viewed from a cross section taken generally perpendicular toan elongate axis 2 of the sheath 3. Rods 50 with curved surfaces thatprotrude into the lumen, such as circular or ellipsoidal surfaces, havethe advantage of reducing the area of contact, and therefore thefriction, between the sheath and a passing object. Longitudinallyextending rods also minimize dimensional change in the longitudinaldirection when the sheath is under tension.

Components described as elastic herein can be constructed of elastomers,such as a highly elastic polymer. In some implementations, theelastomeric portion can include polyether, polyurethane, silicone,thermoplastic elastomers, rubber such as styrene-butadiene rubber, or acopolymer of any of the afore-listed highly elastic polymers. Theelastomeric material can have an elongation of around 800%. In someimplementations, the elastomeric components can comprise a NEUSOFTpolymer. The hardness of the NEUSOFT polymer can be, for example, 63Shore A. NEUSOFT is a translucent polyether urethane based material withgood elasticity, vibration dampening, abrasion and tear resistance. Thepolyurethanes are chemically resistant to hydrolysis and suitable forovermolding on polyolefins, ABS, PC, Pebax and nylon. The polyuerthaneprovides a good moisture and oxygen barrier as well as UV stability.

The heightened elasticity of various elastic layers, such as layers 20,62 and 66, facilitates expansion of the layer from its starting profileto allow for the passage of a prosthetic implant 5 and/or deliverycapsule 13. In some implementations, an in particular for passage of acapsule containing a stent-mounted prosthetic implant, the lumen canexpand to 0.15-0.4 inches, in a fully expanded state. For example, inone implementation, the original diameter of the lumen is 0.13 inches,expands to 0.34 inches during passage of an implant, and shrinks back to0.26 inches immediately after passage of the implant and continues toshrink with time until eventually returning back to about 0.13 inches.After the passage of the implant, the lumen collapses back to a narrowerdiameter due to the elasticity of the elastomeric components.

The non-elastomeric components of embodiments described herein(sometimes particularly described as stiff) are made of a generallystiff material that is less elastic than the elastomeric components. Thestiff components lend strength to the sheath 3 to complement the elasticproperties contributed by the elastomeric components. The stiffer,non-elastomeric components also contribute to buckle resistance(resistance to failure under pressure), kink resistance (resistance tofailure during bending), and torque (or ease of turning the sheathcircumferentially within a vessel). The stiff material used to fabricatethe stiff components can include high density polyethylene (HDPE),Nylon, polyethylene terephthalate (PET), fluoropolymers (such aspolytetrafluoroethylene or PTFE), Polyoxymethylene (POM) or any othersuitably stiff polymer. The elongation of the non-elastomeric, stiffcomponents can be, for example, around 5%. The hardness of an HDPEnon-elastomeric, stiff component can be, for example, around 70 Shore D.

The non-elastomeric components can also be made of a material that ismore lubricious than the elastomeric components, and so as to reducefriction between components and/or the components and the implant 5,capsule 13 or other adjacent contacting objects.

Embodiments disclosed herein can be employed in combinations with eachother to create sheaths with varying characteristics. FIG. 13 showscombination of two single-layer tubes nested into each other. Each ofthe single layer tubes includes a stiff wall portion 52 having a C-shapeand an elastic wall portion 54 to close the C-shape around lumen 32.Each single layer tube also includes rods 50 in a similar configurationto the embodiment of FIG. 6B. One of the single layer tubes has asmaller diameter and fits within the lumen 32 of the other tube. Theadvantage of this combination is a more balanced distribution of elasticwall portions 54 on both sides of the tube which in turns distributesthe strains of expansion. The other embodiments disclosed herein can benested within each other to adjust expansion resistance anddistribution.

FIGS. 14, 15 and 16 show variations of the sheath 3 that include stiffwall portion 52 and elastic wall portion 54, with the elastic wallportion having a lesser wall thickness for additional flexibility incomparison with the stiff wall portion 52. In these embodiments the wallportions can have the same material with the additional flexibilitybeing due to the reduced thickness. Or the reduced thickness can becombined with more elastomeric material composition.

FIG. 14 shows an embodiment of the sheath 3 with a C-shaped stiff wallportion 52 combined with a thin elastic wall portion 54. FIG. 15 showsthe use of two elastic wall portions 54 and two thick, stiffer wallportions 52 on opposing sides, positioning the strain of expansion onopposing sides of the sheath 3. FIG. 16 shows an embodiment of thesheath 3 with more than half or ⅔ or ¾ of the circumference of thesheath being a thinned elastic wall portion 54.

FIGS. 17, 18 and 19 show embodiments wherein wires 78 or strips 80 canbe embedded into structures 82 to selectively reinforce an expandable,elastic tubular layer 81. The structures 82 can be thickened mounds orfeatures applied longitudinally—such as be co-extrusion—to the outsidesurface of the elastic tubular layer 81. The wires or strips can beconstructed of relatively stiffer materials for selective reinforcement.FIGS. 17 and 18 show the use of wires 78 and, for increased stiffness,FIG. 19 shows the use of a strip 80 embedded in the structure 82.

The sheaths of FIGS. 14-19 can be manufactured as described above,including via reflowing, gluing, bonding, welding, etc. Materials caninclude HDPE or TECOFLEX for the stiffer components. Other materialsherein can also be used for stiff or elastic components. Also, thematerials compositions can be varied to include metals, ceramics andother materials than just polymers. Other features can be applied to theembodiments of FIGS. 14-19 including a lubricious liner, hydrophilic orother coatings, silicone or other liquids or printing.

As shown in FIGS. 20-23, another embodiment of the sheath 3 can includea stent structure 84 for embedding in an elastic tubular layer. Thestent 84 can include a plurality of loops 88 facing in oppositecircumferential directions and that interdigitate between (FIGS. 21-23)or adjacent each other (FIG. 21) so as to be able to open up underpressure of the implant 5 passing therethrough. FIG. 20 shows anadditional full circular winding 90 in between each of the loops 88 foradditional stiffness. FIGS. 21, 22 and 23 show the progressive expansionof the lumen within the stent 84 as the implant 5 passes therethrough.The stent 84 can have varying lengths and in the illustrated embodimentsis used for the distal end of the sheath 3. The stent 84 could alsoinclude a heat fused tip on its distal end as shown in otherembodiments.

The stent 84 is a shaped frame that can be formed from a laser cut tubeor by bending wire into the frame. Similar to the C-shaped stiff tubes,the stent 84 results in an off-center axial load during passage of theprosthetic implant 5. The adjacent relationship of the loops 88 and/orwindings 90 provide for excellent pushing stiffness to resist bucklingwhile still having circumferential/radial expandability. Thus, thesheath has a particularly high ratio of buckling to expansionforce—allowing for good articulation with easy expansion. The stent 84is also particularly suited for protecting delicate implants 5, likestent-mounted prosthetic heart valves. The stent 84 can be coated bypolymers for hemostatic sealing and protection of the externalstructures of the prosthetic implant 5.

Other advantages are provided by an expandable introducer sheath for adelivery of an implant mounted on a catheter. The sheath includes anelastic outer tubular layer and an inner tubular layer having a thickwall portion integrally connected to a thin wall portion. The innertubular layer can have a compressed condition/folded configurationwherein the thin wall portion folds onto an outer surface of the thickwall portion under urging of the elastic outer tubular layer. When theimplant passes therethrough, the outer tubular layer stretches and theinner tubular layer at least partially unfolds into an expanded lumendiameter to accommodate the diameter of the implant. Once the implantpasses, the outer tubular layer again urges the inner tubular layer intothe folded configuration with the sheath reassuming its smaller profile.In addition to a reduced initial profile size, the integral constructionof the inner tubular layer guards against the leaks and snags of priorart split-tube and uniform thickness liner combinations. The sheath mayalso include selectively placed longitudinal rods that mediate frictionbetween the inner and outer tubular layers to facilitate easy expansionand collapse, thereby reducing the push force needed to advance theoversized implant through the sheath's lumen.

FIG. 24 shows an implementation of the elastic outer tubular layer 140including a plurality of longitudinal rods 160. The longitudinal rods160 extend the length of the outer tubular layer 140 and protrude intothe initial elastic lumen 158. The longitudinal rods 160 are coupled tothe outer tubular layer, such as by being co-extruded and/or embeddedinto the elastic material of the outer tubular layer, as shown in FIG.25. Advantageously, the longitudinal rods 160 are configured to providea bearing surface to facilitate relative movement of the inner tubularlayer 142 within the outer tubular layer 140. This is especially helpfulwhen the inner tubular layer 142 is unfolding and returning to itsoriginally folded shape.

The longitudinal rods 160 may be circumferentially spaced about theinside surface of the outer tubular layer 160. Although fifteenlongitudinal rods 160 are shown in the cross-section of FIG. 24, anynumber, including a single one, of longitudinal rods may be employed.Also, the longitudinal rods 160 need not extend the entire length of theouter tubular layer 160. They may instead be applied selectivelydepending upon the demands of the implant, application and othercircumstances. Longitudinal rods 160 may be selectively left out of anoverall spacing pattern, such as in FIG. 24 where approximately 90degrees of the inside surface of the outer tubular layer 140 is left asan unadorned surface.

As shown in FIGS. 26-29, other embodiments of the sheath may include aconventional C-shaped inner tubular layer 142 surrounded by an elasticouter tubular layer 140 employing longitudinal rods 160. (FIGS. 26-29may also use other types of inner tubular layer 142, such as theintegrally formed ones disclosed herein.) FIG. 26 shows use of sevenlongitudinal rods equally spaced from each other about the interiorsurface of the outer tubular layer 140 with the exception that a rod ismissing from a portion adjacent a split in the inner tubular layer 142.This gap facilitates distraction and return of the free edges of theC-shaped inner tubular layer 142. FIG. 27 shows a similar arrangementbut with the eighth longitudinal rod 60 present. But the rod is somewhatoffset from the location of the free edges of the inner tubular layer142. Furthermore, the rods of FIG. 27 protrude outward from the outersurface of the outer tubular layer 140 to lower friction between thesheath and, for example, a body lumen or an additional outer deliverysheath.

FIG. 28 shows another embodiment wherein rods are embedded in the outertubular layer 140 and extend from the inside and outside surfacesthereof in alternation. This can lower friction from advancement of thesheath wherein, for example, the outer surface of the layer 140 touchesa body lumen or additional outer delivery sheath. FIG. 29 shows anotherembodiment wherein the inner tubular layer 142 also includes a pluralityof longitudinal rods 160 that facilitate, for example, easy passage ofthe implant 112.

The outer tubular layer 40 in the configurations of FIGS. 26-29 stillcan have a highly elastic, thin structure to fit over the conventionalC-sheath inner tubular layer 142. As the outer tubular layer 140 is notadhered to the inner tubular layer 142, there is free movement betweenthe sleeve and the delivery catheter. The outer tubular layer 140 isalso seamless to guard against blood leakage. The sheath is stretchedevenly along all segments in a radial direction—reducing the risk oftearing or fracture. And, the elastic outer tubular layer 140 will urgethe C-shaped sheath back into the reduced profile configuration. Duringconstruction, the inner layer 142 is easily fitted inside the outerlayer 140 without flattening or heat wrapping. Implementations mayinclude a large number of longitudinal rods 160—even 100 or moredepending upon their cross-sectional size. The longitudinal rods 160 mayinclude microstructure patterns that further reduce friction.

FIGS. 30 and 31 show yet another embodiment of the sheath including asegmented outer tubular layer 140 having longitudinal rods 160 that maybe employed with or without an inner tubular layer 142. As shown in FIG.30, the outer tubular layer 140 has elongate cuts or grooves that formelongate segments 176 extending axially along inner surface. Formed ormounted along the grooves are the longitudinal rods 160. Thelongitudinal rods 160 are shown in FIG. 30 to have curved or arc-shapedtop surfaces that reduce friction for passing implants 112. Thelongitudinal rods 160 are comprised of relatively high stiffnessmaterials such as HDPE, fluropolymer and PTFE. The outer tubular layer140 can be constructed of highly elastic materials with a low tensileset (TPE, SBR, silicone, etc.) to facilitate recovery after expansion.When used without an inner tubular layer 142, the outer tubular layer140 can have additionally lowered expansion force—especially because thehigher strength material (the rods) are not connected in the radialdirection. Other variations may include changing the number and shape ofthe rods 160, incorporation of a tie layer or undercut/bard tostrengthen the connection of the rods to the outer layer 140 and addingsections of stiff material to the outside of the outer layer forimproved stiffness and pushability. A slip additive may be applied tothe surfaces to increase lubricity. FIG. 31 shows the bulge in sheath108 as the implant 112 passes therethrough.

FIGS. 32-34 show another embodiment wherein a distal end of a tubularwall structure 134 can have a flared portion 178. The flared shape ofthe flared portion 178 helps to reduce snags or interference duringretrieval experienced with conventional sheaths during retrieval ofmedical devices. The flared portion 178 is folded or wrapped around thetapered distal end of an introducer to maintain a low profile foradvancement, as shown in FIGS. 32 and 34. The number and size of thefolds may vary depending upon the size and material type of the tubularwall structure 134. For example, FIG. 34 shows three folds in across-sectional view. After the distal end of the sheath is in position,an introducer 180 is removed. Then, the sheath is ready to receive thedelivery catheter and implant. When the implant reaches the flaredportion 178 the folds then break and expand into the flaredconfiguration, as shown in FIG. 33. The flared portion 178 remains inthis flared configuration for possible retrieval of the implant.

In view of the many possible embodiments to which the principles of thedisclosed invention can be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

What is claimed is:
 1. A sheath defining a central lumen and comprising:multiple longitudinal segments; an expandable inner layer extendingalong the multiple longitudinal segments and comprising at least onelongitudinally extending fold, and an outer tubular layer surroundingthe expandable inner layer and extending along multiple longitudinalsegments, wherein a first longitudinal segment of the sheath comprisesan interdigitating stiffening structure as part of the outer tubularlayer, the interdigitating stiffening structure surrounding theexpandable inner layer and comprising a plurality of protrusions facingin alternating circumferential directions and interdigitating betweeneach other, wherein the first longitudinal segment of the sheath isconfigured to temporarily expand to allow passage of an implant throughthe central lumen by at least partially opening the interdigitatingstiffening structure and at least partially unfolding the at least onelongitudinally extending fold.
 2. The sheath of claim 1, wherein thefirst longitudinal segment comprises an outermost cover as part of theouter tubular layer, the outermost cover configured to stretch toaccommodate a passing implant.
 3. The sheath of claim 1, furthercomprising a second longitudinal segment, wherein the secondlongitudinal segment comprises a plurality of circumferentially spaced,arc-shaped, stiff wall portions as part of the outer tubular layer, theplurality of stiff wall portions extending parallel to and partiallyaround the expandable inner layer.
 4. The sheath of claim 3, whereineach of the stiff wall portions comprises a curved inner surface, acurved outer surface, a first straight edge extending between the curvedinner and outer surfaces, and a straight second edge extending betweenthe curved inner and outer surfaces, and wherein each curved outersurface of a selected stiff wall portion is wider than the correspondingcurved inner surface of the selected stiff wall portion.
 5. The sheathof claim 3, wherein the second longitudinal segment further comprises aplurality of longitudinally extending gaps between longitudinallyextending edges of the stiff wall portions, and the second longitudinalsegment of the sheath is configured to temporarily expand by wideningthe plurality of longitudinally extending gaps and unfolding the atleast one longitudinally extending fold of the expandable inner layer toallow passage of an implant through the central lumen.
 6. The sheath ofclaim 5, wherein a first longitudinally extending fold of the expandableinner layer is positioned between two circumferentially spaced stiffwall portions.
 7. The sheath of claim 6, wherein when the sheath is inan unexpanded configuration, the first longitudinally extending fold islocated radially inward of and is at least partially radially alignedwith a first longitudinally extending gap.
 8. The sheath of claim 6,wherein the first longitudinally extending fold is configured to atleast partially unfold during expansion of the expandable inner layer,and wherein the at least partially unfolded portion of the firstlongitudinally extending fold is at least partially radially alignedwith a first longitudinally extending gap.
 9. The sheath of claim 3,wherein the expandable inner layer comprises multiple longitudinallyextending folds, wherein each longitudinally extending fold comprisesportions of the expandable inner layer arranged in an overlappingconfiguration that move to a less overlapping configuration to allowpassage of an implant therethrough, thereby increasing a diameter of thecentral lumen.
 10. The sheath of claim 9, wherein when the sheath is inan unexpanded configuration, overlapping portions of the multiplelongitudinally extending folds extend along a length of the expandableinner layer, and the overlapping portions extend generally parallel toand partially around a central longitudinal axis of the sheath.
 11. Thesheath of claim 9, further comprising a first longitudinally extendingfold and a second longitudinally extending fold circumferentially spacedaround the expandable inner layer from the first longitudinallyextending fold, the first and second longitudinally extending foldslocated radially inward of at least two stiff wall portions.
 12. Thesheath of claim 11, wherein the first and second longitudinallyextending folds at least partially unfold during expansion of theexpandable inner layer, the at least partially unfolded portion of thefirst longitudinally extending fold being at least partially radiallyaligned with a first longitudinally extending gap between two stiff wallportions, and the at least partially unfolded portion of the secondlongitudinally extending fold being at least partially radially alignedwith a second longitudinally extending gap between two stiff wallportions.
 13. The sheath of claim 11, further comprising a thirdlongitudinally extending fold circumferentially spaced around theexpandable inner layer from the first and second longitudinallyextending folds, wherein the first, second and third longitudinallyextending folds are equally spaced circumferentially around theexpandable inner layer.
 14. The sheath of claim 13, wherein the at leasttwo stiff wall portions include a first, second and third stiff wallportion each extending along a length of the second longitudinalsegment, the first, second and third stiff wall portions orientedgenerally parallel to each other and extending in a direction generallyparallel to a central longitudinal axis of the sheath, wherein thefirst, second, and third longitudinally extending folds each at leastpartially unfold during expansion of the inner member, and wherein theat least partially unfolded portions of the first, second, and thirdlongitudinally extending folds are at least partially radially alignedwith corresponding first, second and third longitudinally extending gapsbetween the first, second and third stiff wall portions.
 15. A method ofdelivering an implant, the method comprising; positioning a sheathwithin the vasculature of a subject, advancing the implant into a lumenof the first longitudinal segment of the sheath, exerting an outwardlydirected radial force on the inner surface of a first longitudinalsegment of the sheath via the implant, at least partially unfolding atleast one longitudinally extending fold of an inner expandable layer ofthe first longitudinal segment via the outwardly directed radial force,at least partially opening an interdigitating stiffening structure of anouter tubular layer of the first longitudinal segment via the outwardlydirected radial force, advancing the implant into a lumen of the secondlongitudinal segment of the sheath, exerting an outwardly directedradial force on the inner surface of the second longitudinal segment ofthe sheath via the implant, at least partially unfolding at least onelongitudinally extending fold of an inner expandable layer of the secondlongitudinal segment via the outwardly directed radial force, widening aplurality of longitudinally extending gaps of the outer tubular layer ofthe second longitudinal segment via the outwardly applied radial force,positioning the implant within the vasculature of the subject.
 16. Themethod of claim 15, wherein the interdigitating stiffening structuresurrounds the expandable inner layer and comprises a plurality ofprotrusions facing in alternating circumferential directions andinterdigitating between each other.
 17. The method of claim 16, whereinopening the interdigitating stiffening structure comprises sliding theinterdigitating protrusions circumferentially with respect to eachother.
 18. The method of claim 17, wherein opening the interdigitatingstiffening structure comprises sliding a plurality of ends of theprotrusions circumferentially toward each other and then away from eachother.
 19. The method of claim 18, wherein opening the interdigitatingstiffening structure comprises moving a plurality of ends of theprotrusions away from each other so as to introduce an elongated spacein the outer tubular layer.
 20. The method of claim 15, wherein at leastpartially unfolding at least one longitudinally extending fold of aninner expandable layer of the first longitudinal segment via theoutwardly directed radial force comprises at least partially unfoldingthree circumferentially spaced longitudinally extending folds of theinner expandable layer of the first longitudinal segment.